The FDA's Message Testing: Putting Health Literacy Advice into Practice.

Acting on health literacy principles in a large agency requires not only knowledge of the research base, but also creative work to implement the concepts in practice. Sound scientific advice needs practical development, shaped for the specific working environment. For example, the U.S. Food and Drug Administration (FDA) needs to test communications with intended audiences, but must work within constraints including: Widely varied audiences Significant time pressure Complying with multiple reviews designed to protect potential message testers Testing messages with the intended audiences is a basic communications responsibility, not just an option. Yet, how to do the testing can be challenging. The FDA's experience suggests two practical approaches for user testing: Internal message testing with a network of employee volunteers External message testing with consumer panelists The report briefly explains how the FDA assesses some public communication internally and externally to attain insights about a target audience or a health message as well as discover how a communication might be modified to improve its usability by an intended audience. The report suggests internal or external message testing is superior to controls (no testing) and such testing can be accomplished by a large governmental agency embedded within a complex regulatory environment.

Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.

Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third "rarely" or "never" hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

Biology, ethics, and public policy: deliberations at an unstable intersection.

Biology, ethics, and politics intersect in many public policy issues. The unique features of the meeting point in each case are affected by changes in scientific and technological knowledge, moral analysis in a pluralistic society, and political relations. No one of the three can be ignored without repercussions. This essay, however, concentrates on ethics. The ethical dimension must allow for genuine differences in fundamental moral stance, which always persist alongside scientific developments. Two scientific/medical issues with considerable ethical and political implications are discussed: (1) application of human embryonic stem cell research in regenerative medicine and (2) neuroscientific reductionism in the context of behavioral research and moral responsibility. Public advisory committees and other governmental structures for pursuing public policy should not rely merely on cost-benefit analysis to form policy, as if it were uniquely objective, but should also recognize the necessity of considering science and ethics together as two separate yet complementary foundations of policy. Minimizing the distinctness of the biological and ethical dimensions will make any conclusions unstable and their later implementation more difficult.